New drug that could save the US billions one step closer to approval
Recommendation from the US FDA expected by September on new drug for arthritis and autoimmune diseases
A US Food and Drug Administration advisory committee just gave a critical recommendation for a version of Humira, the blockbuster arthritis drug made by AbbVie that brought in US$14 billion in sales in 2015.
The panel voted unanimously in favour of licensing ABP 501, the version of Humira that's made by Amgen.
The drug is called a "biosimilar," which is like a generic version of a biologic medication, a medicine produced by living cells.
Biosimilars are a bit more complicated than your average competing medicine: Unlike generics for chemical-based drugs like antibiotics, which can be interchangeable with branded versions, the copycats of biologic medications have a few more caveats.
So far, the FDA has approved two. The first is a version of Remicade, or infliximab, a drug used to treat autoimmune diseases like Crohn's disease and rheumatoid arthritis. Another one called Zarxio was approved in 2015. An FDA panel is also evaluating a biosimilar version of Amgen's Enbrel, another drug used to treat autoimmune diseases including RA, psoriatic arthritis, and plaque psoriasis.
The FDA doesn't necessarily have to follow the panel's recommendation, and a final decision on the approval of the drug will be made by September.
"The Committee's favorable vote is an exciting step toward recognising ABP 501 as an important treatment option for patients with inflammatory diseases," said Dr. Sean Harper, Amgen's executive vice president of R&D. "We look forward to continuing to work with the FDA as they complete their review of Amgen's BLA for ABP 501."